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RECRUITING
NCT07074002
PHASE2

Proof of Concept Study on BP1.4979 Effect on Essential Tremor

Sponsor: Bioprojet

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if drug BP1.4979 works to treat essential tremors in adults. It will also learn about the safety of drug BP1.4979. The main questions it aims to answer are: * Does the drug BP1.4979 reduce tremors in individuals with essential tremor? * Do participants have a good safety and tolerability of drug BP1.4979? Researchers will compare drug BP1.4979 to a placebo (a look-alike substance that contains no drug) to see if drug BP1.4979 works to treat essential tremors. Participants will: * Take the study drug (active or a placebo) twice daily over a 4-week period * Visit the clinic 5 times for health checkups and questionnaires completion over a period of approximately 7 to 10 weeks * Complete a diary weekly to assess the impact of essential tremor on daily life

Official title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of BP1.4979 in Adult Patients With Essential Tremor

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-09-17

Completion Date

2026-12

Last Updated

2025-12-16

Healthy Volunteers

No

Interventions

DRUG

BP1.4979

Selective dopamine D3 partial agonist

DRUG

Placebo

Matching placebo of BP1.4979 tablet

Locations (14)

CHU Amiens-Picardie

Amiens, France

CHU Besançon

Besançon, France

Hospices Civils De Lyon Hôpital Neurologique Pierre Wertheimer

Bron, France

CHU de Clermont-Ferrand - Hôpital Gabriel Montpied

Clermont-Ferrand, France

CHU Henri Mondor

Créteil, France

CHU de Lille - Hôpital Roger SALENGRO

Lille, France

Centre Hospitalier Régional De Marseille - Hôpital de la Timone

Marseille, France

CHRU Nancy - Hôpital Central

Nancy, France

CHU de Nice - Hôpital Pasteur 2

Nice, France

CHU de Nîmes

Nîmes, France

CHU Poitiers

Poitiers, France

CHU Rennes - CHU Pontchaillou

Rennes, France

Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

Strasbourg, France

CHU Purpan - Bâtiment Pierre Paul Riquet

Toulouse, France